GUEST COLUMNISTS

• Dynamic Flux Analysis Offers Faster Metabolic Modeling Than DOE

  By continuously analyzing spent media, researchers can estimate reaction rates at regular time points, providing a granular view of cell metabolism.

• Green Supply Chains Rarely Start With A Pledge; Target Waste Instead

  Effective sustainability strategies in pharma supply chains reduce rework and overage. Three leakage points offer the most practical starting point for rooting out waste.

• The Real Reason We Haven't Fully Automated Cell Therapy Yet

  Manual cell therapy workflows often set the tone for automation. This discussion suggests the approach is flawed and presents automation as a chance to innovate.

• The Firefighting Era Of Clinical Supply Chain Is Over. Here's What Replaces It

  Clinical trial supply chains are evolving: digital twins, on-demand kits, and sustainable logistics replace reactive firefighting with precision, speed, and resilience.

• The Hidden Engineering Behind Successful Upstream Bioprocessing

  In upstream biopharmaceutical production, manufacturing is inseparable from biology, engineering, contamination control, and quality science.

• A Practical Look At Modern Downstream Processing For Biologics

  Part 2 in a series about current bioprocessing practices explores the latest in separation, purification, sterile filtration and aseptic filling.

• Process Engineering's Key Role In Sterile Injectable Facility Design

  Quality requirements for parenteral drugs complicate facility design like few other regulated products. If you're developing injectables, be aware of these key issues.

• What To Know About — And How To Apply For — FDA's PreCheck Pilot

  FDA has now provided specific eligibility and selection criteria for the PreCheck Pilot Program and a timeline for next steps.